Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony

Not Applicable

Not yet recruiting

• Conditions: Blood Loss, Surgical; Blood Loss, Postoperative; Uterine Atony
• Interventions: Drug: Calcium Gluconate; Other: Saline

• Registration Number: NCT07217899
• Lead Sponsor: University of Michigan

Brief Summary

This research study is being done to learn what effect a single dose of calcium gluconate will have on blood loss at the time of cesarean delivery in pregnancy patients at high risk for uterine atony.

Detailed Description

This study is FDA IND exempt

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-14
• Study First Submitted QC: 2025-10-14
• Last Update Submitted: 2025-10-14
• Study Start: 2025-10-15
• Study First Posted: 2025-10-20
• Last Update Posted: 2025-10-20
• Primary Completion: 2026-07
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

• English speaking

• Viable Intrauterine Pregnancy, Gestational Age ≥24 weeks

• Labor Converted to Cesarean Delivery at High Risk for Atonic Bleeding Defined as: Any exposure to oxytocin infusion for labor augmentation or induction prior to cesarean delivery

• Or Scheduled Cesarean Delivery at High Risk for Atonic Bleeding Defined as scheduled Cesarean-Section (CS) plus any one of:

  1. > 4 Prior deliveries
  2. General anesthesia
  3. Multifetal gestation
  4. Polyhydramnios diagnosed by ultrasound within 2 weeks
  5. Macrosomia ≥ 4000gms; estimated fetal weight by palpation or by ultrasound
  6. Fibroid uterus, defined as: Multiple ≥ 2cm intramural
  7. Any history of prior Primary postpartum hemorrhage (PPH)
  8. Platelets < 100,000 (but >50,000
  9. Placenta Previa
  10. Body Mass Index (BMI) ≥ 40

Exclusion Criteria

• Non-English speaking

• Antenatal suspicion for placenta accreta spectrum

• History of allergic reaction to Calcium Gluconate

• Patients with hypertensive disorder of pregnancy receiving Magnesium Sulfate for seizure prophylaxis

• Underlying Renal Disease defined as Cr>1.0

• Known underlying cardiac condition

• Cardiac glycosides (Digoxin) within two weeks for maternal or fetal indication

• Treatment with a calcium channel blocker medication within 24 hours of screening

• Hypertensive disorder necessitating intravenous antihypertensive medication within 24 hours of screening

• Emergent case where study participation could impede care (judgement of obstetrician or anesthesiologist)

• Known hypercalcemia

• Concurrent use of any drugs that may cause hypercalcemia including

  1. Vitamin D
  2. Vitamin A
  3. Thiazide Diuretics
  4. Calcipotriene
  5. Teriparatide

• Ceftriaxone within 48 hours of screening

• Total Parenteral Nutrition (TPN) within 48 hours of screening

• Known Coagulopathy International Normalized Ratio (INR) ≥ 1.5

• Vaginal delivery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Calcium Gluconate	Randomized to receive intervention
Arm 2	Saline	Randomized to receive placebo

Primary Outcome Measures

Name	Time	Method
Quantitative Blood Loss (QBL) (continuous variable) administered at Delivery	Immediately following surgery	Standardized volumetric assessment of blood loss during cesarean section

Secondary Outcome Measures

Name	Time	Method
Postpartum hemorrhage	4 hours following surgery	Quantitative blood loss ≥1000mL
Intensive Care Unit Admission	Within 48 hours of cesarean section	Assessed using medical records
Quantitative Blood Loss (QBL) (continuous variable) Total	4 hours following surgery	Standardized volumetric/gravimetric assessment of blood loss during cesarean section
Number of patients with a transfusion requirement	Calculated at 48 hours from delivery	Any transfusion prior to discharge
Change in Hematocrit (HCT)	Preoperative day one, Postoperative day one	Preoperative HCT and Post operative HCT measured though blood sample
Change in Hemoglobin (HGB)	Preoperative day one, Postoperative day one	Preoperative HGB - Post operative HGB measured though blood sample
Number of participants with second line uterotonic requirements	Calculated at four hours from surgical end	specific items of interest: Methylergonovine, Carboprost, or Misoprostol
Additional hemostasis procedures	Within 48 hours of cesarean section	Defined as requiring: Balloon Tamponade, Other atony device, B-Lynch, Uterine artery Ligation (Suture), Uterine Artery Embolization, Hysterectomy

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States